Trial Information

PROJECT SUMMARY OVERVIEW: The purpose of this study is to determine if botulinum toxin type
A (Btx-A) is an effective treatment for painful neuromas. The ideal therapy for painful
neuromas would be effective, non-addictive, safe, localized, and cost-effective, but would
also address the complex peripheral and central mechanisms. Btx-A is a potential treatment
that addresses each of these requirements while preserving the existing sensation and
function. The investigators believe that Btx-A will be effective in eliminating both the
exaggerated local pain response and centralization while maintaining an exceptional safety
profile and potential for long-term effects without addictive properties.

STUDY AIMS: The aims of this proposal are to 1) examine the short-term efficacy of Btx-A
injection compared to placebo in treating pain due to nerve damage, and 2) describe the
long-term efficacy of Btx-A injection in treating pain due to nerve damage by measuring
patient satisfaction and quality of life changes over time.

APPROACH: Forty patients will be enrolled; twenty to receive active treatment (Btx-A) and
twenty to receive placebo (saline). Comparisons between treatment and placebo will occur
during the first 28 days to determine Btx-A's short-term efficacy. Telephone follow-up
visits will occur on Day 2 and Week 1. On Day 28, a telephone follow-up visit will occur,
except in patients who are experiencing complications. Patients with complications or
recurrent pain will return for a clinic visit. Post-assessment on Day 28 marks the
beginning of the longitudinal observational study of patient outcomes. Placebo will no
longer be used and patients still suffering from pain will be eligible for additional Btx-A
injections. Patients may receive up to 4 injections of Btx-A during the 1-year study period
if pain recurs. During the study period participants will be followed to collect data on
pain-free intervals, subsequent treatment choices, patient satisfaction, and changes in
quality of life and function. Group comparisons will be made to analyze results. Further
stratifications for data analysis will be made as enrollment numbers allow to control for
additional demographic and disease variables. Quality-adjusted life-years will be calculated
to help determine the societal and individual cost of this treatment.

HYPOTHESIS: The investigators hypothesize that 1) Btx-A injection relieves neuroma pain
better than a placebo within 28 days of injection, and 2) Btx-A injection relieves neuroma
pain for longer than 28 days, improving patient quality of life. Through this study the
investigators intend to further elucidate the efficacy of injected Btx-A on relieving
chronic pain from nerve damage while characterizing the patients for whom this treatment is
most effective.

Inclusion Criteria:

- Male or female

- aged 18-75 years

- diagnosed with neuroma pain

- able to return/be available for follow-up evaluations

- willingness and ability to give informed consent

Exclusion Criteria:

- positive for HIV/AIDS or otherwise immunocompromised

- history of neuromuscular disease

- reported allergy to BOTOX®

- history or symptoms of any significant medical problem in the last year (i.e.,
bradycardia, impaired cardiovascular function, liver disease)

- symptoms of infection or illness with initial enrollment

- pregnant or lactating women

- unable or unwilling to maintain abstinence or use contraception for 28 days following
all injections

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